VACUETTE (MULTI-USE HOLDER) by GREINER MEDITECH, INC.

This device is a Greiner VACUETTE Multi-use Holder, which is a non-sterile reusable plastic device used in routine venipuncture procedures. In this 510(k) summary, the manufacturer is claiming substantial equivalence to Becton Dickinson's preamendment VACUTAINER® Brand holder. The summary does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria.

Here's why and what information is missing:

Type of Device: This is a physical, reusable plastic medical device for venipuncture, not a software-driven or AI-based diagnostic tool. The detailed questions about acceptance criteria, performance studies, sample sizes, ground truth (pathology, outcomes data), expert consensus, MRMC studies, and training sets are primarily relevant to diagnostic algorithms, AI, or imaging devices.
Submission Type: This is a 510(k) premarket notification claiming "substantial equivalence" to a predicate device. For devices like this, substantial equivalence is typically demonstrated through comparisons of material, manufacturing process, intended use, and general performance characteristics that do not involve complex clinical or algorithmic efficacy trials.
Content of the Document: The provided text is a 510(k) summary and the FDA's response letter. These documents describe the device, its intended use, and the FDA's finding of substantial equivalence. They do not typically include detailed study designs, acceptance criteria tables, or performance metrics in the way your questions are structured for AI/diagnostic devices. The regulatory pathway for this type of device does not usually require such studies for 510(k) clearance, especially given the predicate device was preamendment.

Therefore, the requested information cannot be extracted from the provided text for the following points:

A table of acceptance criteria and the reported device performance.
Sample sized used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
Adjudication method for the test set.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc).
The sample size for the training set.
How the ground truth for the training set was established.

For this type of device, a "study"proving acceptance criteria would likely involve:

Material compatibility testing: Ensuring the plastic does not react adversely with blood or commonly used cleaning agents.
Manufacturing quality control: Demonstrating consistent production to specifications.
Dimensional compatibility: Ensuring it fits standard collection tubes and needles.
Functional tests: E.g., ensuring it can hold a tube securely during venipuncture without accidental dislodgement, or that the needle connection is secure.

However, none of these specific details are included in the provided 510(k) summary. The summary focuses on comparing the new device to the predicate device in terms of material (polypropylene plastic) and intended use (routine venipuncture procedures) to demonstrate substantial equivalence, rather than providing detailed performance metrics from a formal study.

Summary

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1974873

I. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS FEB 5, 1998

Greiner Meditech, Inc. ("Greiner") is submitting a 510(k) premarket notification for it's Greiner VACUETTE Multi-use Holder. The VACUETTE & Multi-use Holder is non-sterile reusable plastic device to be used in routine venipuncture procedures.

Greiner is claiming substantial equivalence to Becton Dickinson's preamendment VACUTAINER® Brand holder. The VACUETTE® holder is manufactured from polypropylene plastic as is the Becton Dickinson VACUTAINER® Brand holder. Both devices have the same intended use.

Greiner's 510(k) has been submitted on December 23, 1997 by Doug Harris, Managing Director, Greiner Meditech, Inc., 260 Gateway Drive, Suite 17A, Bel Air, Maryland 21014 (T: 410-836-8228).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with three flowing lines representing hair or a head covering.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FFB - 5 19

Douglas L. Harris Managing Director · Greiner Meditech, Inc. 260 Gateway Drive, Suite 17A P.O. Box 943 Bel Air, Maryland 21014

K974873 Re : VACUETTE® Multi-Use Holder Requlatory Class: II Product Code: JKA Dated: December 22, 1997 December 29, 1997 Received:

Dear Mr. Harris: ......

regulations.

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set " forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known) __

Device Name: VACUETTE & Multi-Use Holder

Indications for Use: To be used in routine venipuncture procedures

Prescription _________________________________________________________________________________________________________________________________________________________________

Over-the-Counter _____________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Clinical Laboratory Levices
510(k) Number 974873

Regulation Number and Section

§ 862.1675 Blood specimen collection device.

(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.